The vaginal speculum is a device which has long been used to visualize the cervix and vaginal walls, as well as to gain trans-cervical access to the uterus. The mechanics of a typical speculum are based on a simple design, one which articulates two "blades" on a handle to expand the vaginal walls in an anterior-posterior, or "front to back" orientation. For years this design has provided adequate exposure and visualization for examining physicians, and allowing for the diagnosis and treatment of vaginal, cervical and endometrial disorders.
Any health care provider familiar with the design and operation of a typical speculum has at one or more times been made aware of its limitations. Most apparently, its basic design is uncomfortable to the patient, and frequently elicits anxiety and apprehension toward the vaginal exam. The prior art speculum design is intended to open the vagina, an oval or `H` shaped structure, with two metal or plastic "duck-billed" blades which diverge relative to one another. The broad, flattened orientation of the blades does not respect the oval contour of the vaginal vault, and its insertion is often uncomfortable or painful to the patient. In addition, the broad anterior blade is subject to compress the patient's urethrae as it courses beneath the pubic bone. This is an uncomfortable situation for the healthy patient and often a desperate one for the patient with a bladder or urethra complication. Common complaints additionally include the sensation of a cold metal tool being placed in the vagina, or simply the difficulties met with its insertion.
From the health care provider's perspective, the tool's objective of providing visualization of the cervix is far from optimal. As the blades may only be opened in a single anterior-posterior plane, there is no support for the lateral "windows" which form as the blades move away from one another. This permits the redundant, fatty and poorly supported tissue on the vaginal sidewalls to bulge inward as the blades are opened, invariably obscuring a portion of, if not the entire cervical margins. This phenomenon is almost the rule, not the exception, in obese or multiparous patients.
A vicious cycle then ensues with the prior art design. As the vaginal sidewalls collapse inward, the practitioner attempts to improve visualization by opening the tool wider in the hope of stretching the redundant tissue to a point at which they can no longer collapse. This naturally causes great discomfort for the patient and frustration for the care provider. A technique of placing a condom over the blades and cutting a hole in the tip has been used widely to improve visualization, while other physicians have opted for the expense and inconvenience of using lateral wall retractors in the vagina to supplement the speculum. The former method is sub-adequate as it severely limits visualization, mobility and speculum expansion. The latter method is impractical, expensive, and crowds two tools into an already limited work space. Further, since the typical speculum is only applicable in a minimum number of sizes without interchangeable blades, it is not readily adapted to be used with a variety of different patients and anatomies associated therewith.
Conventional speculum designs not only limit visualization of the cervix, but frequently induces tissue trauma. As the two blades are positioned and opened, the top blade is opened and dragged across the cervix. With a frequent and uncomfortable "pop" the cervix is scraped along the anterior blade as it comes into view. With friable or inflamed tissue this immediately causes bleeding and pain, further compromising the exam. Thus, the cervix and vagina are often poorly visualized and sampled, compromising the screening, diagnosis, and treatment of genital pathology.
One attempt to design a more efficient and patient friendly speculum is described in U.S. Pat. Nos. 5,505,690 and 5,377,667 to Patton. The device disclosed in these patents utilizes a plurality of plastic blades pivotally interconnected to a base. The blades have distal ends which move outwardly when the handle is depressed. The outward movement is accomplished by a traveling ring being pushed forward in a linear direction with an actuator and the base which is interconnected to the rearward handle. Unfortunately, the device is difficult to open based on the mechanics of the opening mechanism, has blade tips which are too large, thus causing pain and discomfort in many patients. Further, the Examining "window" is inherently small due to the design and the handle is inconveniently located directly behind the longitudinal axis of the blades.
Thus, with the aforementioned limitations in mind, an improved speculum design would be extremely advantageous which offers increased patient comfort, improved visualization and greater adaptability for the care provider.